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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Actavis and Adamas announce FDA approval of Namzaric, a fixed-dose combination of memantine hydrochloride extended-release and donepezil hydrochloride
Actavis plc and Adamas Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Namzaric, ...
Posted by Michael Wonder on 05 Aug 2015
AbbVie's Humira (adalimumab) receives U.S. FDA approval for extension of polyarticular juvenile idiopathic arthritis indication to patients ages 2 years and older
AbbVie today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the Humira indication for moderately to severely ...
Posted by Michael Wonder on 05 Aug 2015
Iroko Pharmaceuticals announces acceptance of U.S. filing for SoluMatrix meloxicam in osteoarthritis pain
Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today that the U.S. ...
Posted by Michael Wonder on 05 Aug 2015
FDA Fast Track Designation granted to luspatercept for the treatment of patients with beta-thalassemia
Celgene Corporation and Acceleron Pharma Inc. today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designations ...
Posted by Michael Wonder on 05 Aug 2015
FDA accepts Sandoz application for biosimilar filgrastim
Sandoz, a Novartis Group company, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License ...
Posted by Michael Wonder on 05 Aug 2015
Boehringer Ingelheim statement on hepatitis C drug development
20 June 2014 - Boehringer Ingelheim has re-evaluated its strategy in hepatitis C (HCV), and as a result the company has decided ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer announces FDA acceptance of and priority review designation for biologics license application for investigational meningococcal B vaccine
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Corlanor to treat heart failure
The U.S. Food and Drug Administration today approved Corlanor (ivabradine) to reduce hospitalization from worsening heart failure. ...
Posted by Michael Wonder on 05 Aug 2015
US breakthrough status for Genentech's Lucentis
US regulators have assigned Genentech’s VEGF inhibitor Lucentis (ranibizumab) breakthrough therapy status as a treatment for diabetic retinopathy. ...
Posted by Michael Wonder on 05 Aug 2015
Brilinta receives US FDA approval for new administration option
AstraZeneca today announced that the US Food and Drug Administration has approved a new administration option for acute coronary syndrome (ACS) patients ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA grants priority review status to NDA for anticancer agent lenvatinib
Eisai Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application ...
Posted by Michael Wonder on 05 Aug 2015
Galderma receives FDA approval for new antibiotic-free treatment option for acne patients
Galderma Laboratories, L.P. announced today that the U.S. Food and Drug Administration (FDA) approved antibiotic-free Epiduo Forte (adapalene and benzoyl peroxide) ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new type of sleep drug, Belsomra
The U.S. Food and Drug Administration today approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling ...
Posted by Michael Wonder on 05 Aug 2015
FDA expands approval of Pernix's migraine therapy Treximet in paediatric patients
Pernix Therapeutics Holdings, Inc. a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Treximet (sumatriptan ...
Posted by Michael Wonder on 05 Aug 2015
FDA expands approved use of Imbruvica for rare form of non-Hodgkin lymphoma
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for patients with Waldenström’s macroglobulinemia (WM), ...